The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hi-lo Temp Thermocouple To Thermister Adaptor.
| Device ID | K844201 |
| 510k Number | K844201 |
| Device Name: | HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls, NY 12301 |
| Contact | Philip E Wiegert |
| Correspondent | Philip E Wiegert MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls, NY 12301 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-30 |
| Decision Date | 1985-03-04 |